Helping patients choose between pain control options for outpatient procedural abortion at less than 12 weeks' gestation.

OBJECTIVES: This study aimed to identify predictors of patient satisfaction with their chosen pain control regimen for procedural abortion at <12 weeks' gestation in the outpatient setting. STUDY DESIGN: In this prospective cohort study, we developed an instrument to evaluate predictors of satisfaction with pain control regimens among patients choosing local anesthesia alone (paracervical block with 20 mL of 1% buffered lidocaine) or local anesthesia plus intravenous (IV) moderate sedation with 100 mcg of fentanyl and 2 mg of midazolam. Our primary outcome was to identify predictors of satisfaction with both anesthesia cohorts as measured on a 4-point Likert scale, but due to high satisfaction levels in the IV group, we focused our analysis on the local anesthesia group. RESULTS: We enrolled 149 patients in the local anesthesia group and 155 in the moderate IV sedation group. The mean procedure pain scores were 6.9 (±2.1) out of 10 in the local group and 4.0 (±2.7) in the IV group (p < 0.0001). More women in the IV group (92%) were satisfied or very satisfied with the amount of pain relief they experienced compared to the local group (66%; p < 0.0001). In the univariable model, only being afraid of a minor medical procedure was predictive of less satisfaction with local anesthesia for pain control (relative risk 0.8 [95% CI, 0.6-0.9]). Age, gestational age, anticipated pain, self-reported pain tolerance, self-reported anxiety, discomfort with the abortion decision, and history of prior vaginal or cesarean delivery or induced abortion did not predict satisfaction levels. CONCLUSIONS: Fear of minor medical procedures was the only variable that predicted decreased satisfaction with local anesthesia alone for procedural abortion under 12 weeks. IMPLICATIONS: Reliable predictors for satisfaction with local anesthesia alone for procedural abortion in the outpatient setting remain elusive. Fear of minor medical procedures may serve as an indicator of decreased satisfaction and could be incorporated into patient counseling. Moderate IV sedation is associated with high satisfaction levels.

Acute complications with same-day versus overnight cervical preparation before dilation and evacuation at 14 to 16 weeks.

OBJECTIVE: Evaluate if same-day cervical preparation is associated with a clinically acceptable complication rate compared with overnight osmotic dilators for dilation and evacuation (D&E). STUDY DESIGN: This retrospective, noninferiority, cohort study compared complication rates for same-day versus overnight cervical preparation with D&E between 14 and 16 weeks gestation. Cervical preparation was achieved with misoprostol, osmotic dilators, or both. Our primary outcome was the acute complication rate, defined as: hemorrhage (≥500 mL); hospitalization or hospital transfer; transfusion; or unplanned procedure occurring within 24 hours of the index procedure. Secondarily we evaluated nonmajor (re-aspiration, suture repair of cervical laceration, uterine tamponade, or emergency department only transfer) and major (transfusion, uterine artery embolization, abdominal surgery, or hospital admission) complications separately. Inverse probability of treatment weighting using the propensity score was used to perform an adjusted analysis, taking into account age, ethnicity, clinic location, insurance, gestational age, gravidity, and prior pregnancy outcomes. RESULTS: We analyzed 1,319 subjects (n = 864 same-day, n = 455 overnight). Same-day cervical preparation patients were more likely to have Medicaid and a prior vaginal delivery. In both unadjusted and adjusted analyses, acute complication rates for same-day were noninferior to overnight preparation (unadjusted 0.93% vs 1.98%, difference of -1.05%, CI: -2.48% to 0.38%; adjusted difference -0.50%, CI: -1.45 to 0.44%). Only one major complication in the same-day group, a cervical laceration resulting in hemorrhage requiring transfusion, occurred in the entire sample. CONCLUSIONS: In this retrospective review, same-day cervical preparation was noninferior to overnight preparation for D&E between 14 and 16 weeks gestation, both with low complication rates. IMPLICATIONS: For early second trimester dilation and evacuation, same-day cervical preparation should be considered a safe alternative to overnight cervical preparation.

State and federal abortion restrictions increase risk of COVID-19 exposure by mandating unnecessary clinic visits.

OBJECTIVE: To quantify the number of medically unnecessary clinical visits and in-clinic contacts monthly caused by US abortion regulations. STUDY DESIGN: We estimated the number of clinical visits and clinical contacts (any worker a patient may come into physical contact with during their visit) under the current policy landscape, compared to the number of visits and contacts if the following regulations were repealed: (1) State mandatory in-person counseling visit laws that necessitate two visits for abortion, (2) State mandatory-ultrasound laws, (3) State mandates requiring the prescribing clinician be present during mifepristone administration, (4) Federal Food and Drug Administration Risk Evaluation and Mitigation Strategy for mifepristone. If these laws were repealed, "no-test" telemedicine abortion would be possible for some patients. We modeled the number of visits averted if a minimum of 15 percent or a maximum of 70 percent of medication abortion patients had a "no-test" telemedicine abortion. RESULTS: We estimate that 12,742 in-person clinic visits (50,978 clinical contacts) would be averted each month if counseling visit laws alone were repealed, and 31,132 visits (142,910 clinical contacts) would be averted if all four policies were repealed and 70 percent of medication abortion patients received no-test telemedicine abortions. Over 2 million clinical contacts could be averted over the projected 18-month COVID-19 pandemic. CONCLUSION: Medically unnecessary abortion regulations result in a large number of excess clinical visits and contacts. POLICY IMPLICATIONS: Repeal of medically unnecessary state and federal abortion restrictions in the United States would allow for evidence-based telemedicine abortion care, thereby lowering risk of SARS-CoV-2 transmission.

"Without any indication": stigma and a hidden curriculum within medical students' discussion of elective abortion.

Pregnancy termination is a common, beneficial medical procedure, but abortion care in the United States is stigmatized. Language, including categorization of some abortions as elective, may both reflect and convey stigma. We present a history of the term "elective" in reference to abortion, followed by data demonstrating its use by a sample of contemporary medical trainees and an analysis of the term's relationship to abortion stigma, medical training, and patient access to abortion care. We analyzed interviews with 41 U.S. medical students who had applied to residency programs in obstetrics and gynecology. Participants discussed experiences with, and attitudes toward, abortion before and during medical school, and plans to perform abortions in future practice. We inductively coded participants' use of "elective" in reference to abortion and analyzed their meanings. Participants did not use "elective" according to its medical definition, which conveys an absence of urgency for surgery. Instead, "elective" identified a subset of abortions that lacked maternal or fetal medical indications. "Elective" negatively marked and isolated some abortions, and participants used the term to convey judgment about patients' social and reproductive histories. Participants saw medical and psychosocial indications as mutually exclusive, and became confused when interrelated factors influenced patients' abortion decisions. They ignored the voluntary nature of abortion in the setting of medical illness, sexual violence, or fetal complications, and accepted discrimination against women seeking abortion for psychosocial indications as normal and ethical. The term "elective" enables the creation and perpetuation of abortion stigma, and contributes to a hidden curriculum for abortion training in medical education that distracts from core content, incorporates social judgment of patients into medical practice, and promotes normative gender concepts. Our findings support calls to improve the language of abortion care to ensure policies and training environments are consistent with professional standards.

Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months. METHODS: In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months. RESULTS: From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment. CONCLUSION: Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.

Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of insertion of etonogestrel implants with mifepristone compared with after the abortion on the risks of medical abortion failure and repeat pregnancy over the subsequent 6 months. METHODS: In a randomized trial, we assigned patients undergoing medical abortion to receive etonogestrel implants either with the mifepristone (Quickstart group) or after the abortion (Afterstart group). We followed them for 7 months to ascertain abortion outcome, pregnancies, and contraception use. RESULTS: Between September 2013 and August 2014, we enrolled 236 participants in the Quickstart group and 240 in the Afterstart group. To examine abortion failure, we conducted a noninferiority analysis from which we excluded nine participants who had missing outcome data and four with specified protocol violations. Of the rest, 9 of 229 (3.9%) and 9 of 234 (3.8%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the difference of 0.08% (90% confidence interval -3.1% to 3.3%) excluded our prestipulated noninferiority margin of 5 percentage points. Among participants with pregnancy follow-up through 6 months, 1 of 213 (0.5%) and 3 of 208 (1.4%) in the Quickstart and Afterstart groups, respectively, became pregnant within that time; 6-month pregnancy rates did not differ significantly by group (exact log-rank test, P=.28). At enrollment, significantly more participants in the Quickstart group than in the Afterstart group were satisfied with their group assignments (187/236 [79%] compared with 129/240 [54%], respectively; P<.001). CONCLUSION: Insertion of etonogestrel implants with mifepristone did not appreciably increase medical abortion failure risk and it enhanced patient satisfaction, but we found no evidence that it decreased repeat pregnancy rates. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01902485.

Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial.

OBJECTIVE: To compare the efficacy and acceptability of buccal misoprostol or a synthetic osmotic cervical dilator for cervical preparation before same-day late first-trimester and early second-trimester surgical abortion. METHODS: In this randomized, double-blind trial, we compared 400 micrograms of buccal misoprostol with one synthetic osmotic cervical dilator administered 3-4 hours before surgical abortion among women at 12-15 weeks of gestation. The primary outcome was mean cervical circumferential dilation at the time of surgery. Randomization was stratified by parity and sample size calculated to detect a 3-French difference between groups with 90% power with a two-sided α of .05. Secondary outcomes included ease of further mechanical dilation, procedure time, complications, ripening and procedural pain, and participants' satisfaction. RESULTS: One hundred twenty-five women were randomized with a mean gestational age of 13 3/7 weeks. Treatment with the synthetic osmotic dilator and buccal misoprostol resulted in similar preoperative dilation (mean French 33.9 compared with 32.1, P=.065). Procedure time, procedural pain, number of complications, and participants' satisfaction and preferences did not differ between treatment groups. Misoprostol participants experienced more pain during ripening (P=.008). All but six participants, three in each arm, required mechanical dilation at the time of the procedure. This manual dilation was subjectively easier in participants who received the synthetic osmotic cervical dilator (P=.015). All participants were able to have their procedure in 1 day without further cervical preparation. CONCLUSION: Either buccal misoprostol or a synthetic osmotic cervical dilator provides adequate dilation for same-day late first-trimester and early second-trimester abortion. Despite more pain with misoprostol, patient satisfaction with misoprostol and the synthetic dilator is similar. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, NCT00835731. LEVEL OF EVIDENCE: I.

Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies.

OBJECTIVE: To assess possible risk factors, management, and outcomes for women with malpositioned intrauterine contraception devices (IUDs). METHODS: This retrospective case-control study compared 182 women with malpositioned IUDs shown by ultrasonography at a single institution from 2003 to 2008 with 182 women with properly positioned IUDs. We evaluated whether insertion at 6-9 weeks postpartum, postabortion placement, breastfeeding, type of IUD, pregnancy history, leiomyomas, suspected adenomyosis, and indication for placement were associated with malpositioning. Our study had 70-99% power to detect whether postpartum placement was associated with an odds ratio (OR) of 2-3. RESULTS: Malpositioned devices were noted on 10.4% of ultrasonography scans among women with IUDs having pelvic ultrasonography for any indication. Most malpositioned devices (73.1%) were noted to be in the lower uterine segment or cervix. Insertion of IUDs at 6-9 weeks postpartum was not associated with malpositioning (OR 1.46, 95% confidence interval [CI] 0.81-2.63). Among other possible risk factors examined, suspected adenomyosis was associated with IUD malpositioning (OR 3.04, 95% CI 1.08-8.52), whereas prior vaginal delivery (OR 0.53 95% CI 0.32-0.87) and private insurance (OR 0.38, 95% CI 0.24-0.59) were protective. Approximately two-thirds (66.5%) of malpositioned devices were removed by health care providers. There were more pregnancies within 2 years among those in the case group than those in the control group (19.2% compared with 10.5%, P=.046). All pregnancies were the result of IUD expulsion or removal, and none occurred with a malpositioned IUD known to be in situ. CONCLUSION: Malpositioning of IUDs does not appear to be associated with insertion at 6-9 weeks postpartum. Women with malpositioned IUDs are more likely to become pregnant because of IUD removal without initiation of another highly effective contraceptive method.

Expanding access to intrauterine contraception.

The intrauterine device is a safe, highly effective, long-lasting, yet reversible method of contraception. Expanding access to intrauterine contraception is an important measure to reduce the rate of unintended pregnancy in the United States. Clinicians should consider intrauterine contraception in appropriate candidates, including women who are nulliparous, adolescent, immediately postpartum or postabortal, and desiring emergency contraception, and as an alternative to permanent sterilization. Barriers to intrauterine contraception such as requiring cervical cancer screening before insertion, routine testing for gonorrhea and chlamydial infection in low-risk women, or scheduling insertion only during menses are unnecessary.

Intrauterine adhesions as a risk factor for failed first-trimester pregnancy termination.

BACKGROUND: Risk factors for failed first-trimester surgical abortion include endometrial distortion caused by leiomyomas, uterine anomalies and malposition and cervical stenosis. This report introduces intrauterine adhesions as an additional risk factor. CASE: A multiparous woman presented for pregnancy termination at 6 weeks' gestation. Three suction-curettage attempts failed to remove what appeared to be an intrauterine pregnancy. Rising beta-hCG levels and concern for an interstitial ectopic pregnancy prompted a diagnostic laparoscopy and exploratory laparotomy without the identification of an ectopic pregnancy. After methotrexate treatment failed, the patient underwent ultrasound-guided hysteroscopy and suction curettage using a cannula with a whistle-cut aperture for the successful removal of a pregnancy implanted behind intrauterine adhesions. CONCLUSION: Intrauterine adhesions are a cause of failed surgical abortion. Ultrasound-guided hysteroscopy may be required for diagnosis.

Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates.

OBJECTIVE: Manual vacuum aspiration is an alternative to electric suction curettage for first-trimester elective abortion. Although many studies have demonstrated that manual vacuum aspiration is safer than sharp curettage for abortion, only a few studies have directly compared it with electric suction curettage. These studies proved the methods to be equally effective and acceptable but were too small to adequately compare safety. We compared immediate complication rates for abortions performed by manual and electric vacuum aspiration. METHODS: We conducted a retrospective cohort analysis of all women undergoing elective abortion at up to 10 weeks' gestation at San Francisco General Hospital over a 3.5-year period. A total of 1726 procedures were included: 1002 manual and 724 electric vacuum aspirations. Clinical data were collected from medical records. Rates of uterine reaspiration and other immediate complications occurring at our institution were compared. RESULTS: We found no difference in the rate of uterine reaspiration after abortions performed with the manual or electric suction device (2.2% versus 1.7%, respectively, P =.43). We had 80% statistical power to detect a 2% difference in uterine reaspiration rates with an microa error of.05. Overall major complication rates were 2.5% with manual and 2.1% with electric suction curettage, P =.56. Multivariable regression analyses controlling for potential confounders showed no difference in uterine reaspiration rates (electric odds ratio [OR] = 0.71, 95% confidence interval [CI] 0.32, 1.6) or overall complications (electric OR = 0.81, 95% CI 0.40, 1.7). CONCLUSION: Manual vacuum aspiration is as safe as electric suction curettage for abortions at up to 10 weeks' gestation. Expanded use in an office setting might increase abortion access.

Post-abortion depot medroxyprogesterone acetate continuation rates: a randomized trial of cyclic estradiol.

Irregular menstrual bleeding is a common reason for discontinuation of depot medroyprogesterone acetate (DMPA) contraception. We conducted a double-blind, randomized placebo controlled trial to estimate if transdermal estradiol used in a cyclic fashion could make DMPA bleeding patterns more acceptable and improve DMPA continuation rates. Women initiating DMPA contraception immediately post-abortion (N = 132) were randomized to receive either a low sustained dose of transdermal 17-beta estradiol (0.10 mg/day, Climara) or an identical placebo to be used in a cyclic manner for 3 months. Bleeding patterns, contraceptive use, and pregnancy rates were measured for 1 year after enrollment. Cyclic transdermal estrogen did not create regular bleeding patterns in new users of DMPA and had no effect on DMPA continuation rates (relative hazard = 0.93, 95%CI 0.65-1.33). By 12 months after enrollment, 19.4% of those randomized to estrogen and 23.9% of those randomized to placebo were still using DMPA for contraception. There was no difference in the frequency of DMPA discontinuation primarily for abnormal uterine bleeding between groups (relative risk ratio = 0.95, 95%CI 0.40-2.23). Few women who discontinued DMPA switched to highly effective methods of contraception and within 1 year of an abortion, there were 18 repeat pregnancies (21.9%). Compliance with the estrogen patches was poor resulting in early study termination and inadequate statistical power to detect a clinically significant difference in DMPA continuation rates. Continuation rates of DMPA were low and repeat pregnancy rates were high among women initiating DMPA at the time of abortion. Cyclic transdermal estradiol use is an unacceptable regimen for preventing the irregular bleeding associated with DMPA initiation.